THIS invention relates to fulvic acid as the active ingredient for use in the treatment or inhibition of multi-drug resistant bacteria, in particular NDM-1 bacteria producing carbapenemase or extended-spectrum β-lactamase (ESBL) resistant bacteria. The invention further relates to fulvic acid as an active ingredient in combination with one or more antibiotics from the class of carbapenems or polymyxin antibiotics for use in the treatment of multi-drug resistant bacteria, in particular NDM-1 bacteria producing carbapenemase.
Fulvic acid is a fraction of the humic substances that are formed during the decay of plant and animal residues in the environment (MacCarthy at al., 1985) and that is soluble in water under all pH conditions. It is also generally of lower molecular size and weight and lower in colour intensity than humic acids also found in humic substances.
Typically, fulvic acids have been produced from bituminous coal using a controlled wet oxidation process (Bergh of al., 1997). These fulvic acids are referred to as oxifulvic acids. One such process for production of fulvic acids from coal was described in U.S. Pat. No. 4,912,256.
Such fulvic acids have been used in the treatment of inflammation, acne, eczema, and bacterial, fungal and viral infections such as described in International patent publication WO00/19999. Furthermore, U.S. Pat. Nos. 4,999,202 and 5,204,368 disclose compositions containing fulvic acid, salt or a derivative thereof, which have bacteriostatic or bacteriocidal properties and are useful as disinfectants.
However, fulvic acids derived from oxidation of coal contain high concentrations of heavy metals including aluminium, mercury, cadmium, chromium and lead that are now known to be harmful to humans and should be avoided in pharmaceutical preparations. International patent publication WO2007/125492 discloses a fulvic acid composition derived from a carbohydrate source by a process of wet oxidation and a method of producing such a composition. As a result of the carbohydrate starting material, the fulvic acid produced from this process contains a low content of these harmful elements. Such a composition is described as being useful for pharmaceutical application.